FUNGIFREE NAIL FUNGUS TREATMENT- ketoconazole, tolnaftate solution 
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Fact Label

Active ingredients Purpose

Ketoconazole 1.7%...................................................................................................................Anti-fungal

Tolnaftate 1.0%.........................................................................................................................Anti-fungal

Treatment of fingernail and toenail fungus

Uses

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Stop and ask a doctor if - irritation occurs - there is no improvement within 6 weeks

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

Warnings

Directions

-Soak your nails in warm water for 5 minutes, then dry them.

-Cut and trim affected nails.

-Dip the brush (attached on cap) into the treatment solution.

-Apply the solution over the affected parts, including the root(s) of the nail(s).

-Use 2 times a day, in the morning and before sleep.

Inactive ingredients Aqua, Sorbitol, Ethanol, Propylene Glycol, Salicylic Acid, Deacetylated Chitin, Angelica Dahurica, Lactic Acid, Chlorhexidine Acetate, Laurocapram

Other information store at 10-35°C (50.0-95.0°F)

FUNGIFREE NAIL FUNGUS TREATMENT 
ketoconazole, tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83364-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1.7 g  in 100 g
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LACTIC ACID (UNII: 33X04XA5AT)  
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)  
LAUROCAPRAM (UNII: 1F3X9DRV9X)  
SORBITOL (UNII: 506T60A25R)  
ALCOHOL (UNII: 3K9958V90M)  
ANGELICA DAHURICA VAR. FORMOSANA WHOLE (UNII: 247A107296)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLIGLUSAM (UNII: 82LKS4QV2Y)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83364-005-011 in 1 BOX05/16/2024
1NDC:83364-005-0230 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/16/2024
Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)

Revised: 5/2024
Document Id: 186e7e21-b3f6-1c94-e063-6394a90adaeb
Set id: 186e7e21-b3f5-1c94-e063-6394a90adaeb
Version: 1
Effective Time: 20240514
 
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD